TITAN SPINE, LLC: Medical Device Recall in 2015 - (Recall #: Z-2327-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.

Product Classification:

Class II

Date Initiated: July 20, 2015

Date Posted: August 12, 2015

Recall Number: Z-2327-2015

Event ID: 71740

Reason for Recall:

Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.

Status: Terminated

Product Quantity: 137 units

Code Information:

Lot numbers: V03, V05, V06

Distribution Pattern:

Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.

Voluntary or Mandated:

Voluntary: Firm initiated